Kura Oncology (KURA) risk factors, FY2024 10-K

Risks Related to the Discovery and Development of Our Product Candidates

1. 01Our discovery, preclinical and clinical development activities are primarily focused on the development of targeted therapeutics for patients with genetically defined cancers, which is a rapidly evolving area of science, and the approach we are taking to discover and develop drugs may never lead to marketable products
2. 02We may find it difficult to enroll patients in our clinical trials. Difficulty in enrolling patients could delay or prevent clinical trials of our product candidates
3. 03ambiguous or negative interim results of our clinical trials or results that are inconsistent with earlier results
4. 04there may be changes in governmental regulations or administrative actions
5. 05have the product removed from the market after obtaining marketing approval
6. 06We anticipate that our current product candidates and any future product candidates may be used in combination with third-party drugs or biologics, some of which may still be in development, and we have limited or no control over the supply, regulatory status, or regulatory approval of such drugs or biologics
7. 07Our product candidates may cause serious adverse events or have unacceptable side effects that could delay, limit or prevent their development
8. 08The safety and tolerability observed in the Phase 2 registration-directed KOMET-001 trial were consistent with previous reports
9. 09Our FIT-001 trial represents the first time our KO-2806 compound has been tested in humans. While we can anticipate potential side effects based upon the safety profiles of tipifarnib and other FTIs, we cannot predict the type, frequency or severity of side effects that we will observe in patients treated with KO-2806
10. 10We may expend our limited resources to pursue a specific product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success
11. 11Failure by us or our third-party collaborators to develop, validate and obtain regulatory approval for a diagnostic testing platform could harm our drug development strategy and operational results
12. 12Additionally, we or our collaborators may encounter production difficulties that could constrain the supply of the companion diagnostics, affect the ease of use, affect the price or have difficulties gaining acceptance of the use of the companion diagnostics in the clinical community
13. 13Preclinical and clinical testing of tipifarnib that has been conducted to date may not have been performed in compliance with applicable regulatory standards, which could lead to increased costs or material delays for their further development

Risks Related to Our Financial Position and Need for Additional Capital

1. 14We expect to incur losses over the next several years and may never achieve or maintain profitability
2. 15incur increased costs as a result of continued operations as a public company
3. 16We are a clinical-stage company with no approved products and no historical product revenue. Consequently, we expect that our financial and operating results will vary significantly from period to period
4. 17our ability to build our finance infrastructure and, to the extent required, improve our accounting systems and controls
5. 18Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability
6. 19We may need to obtain substantial additional capital in connection with our continuing operations. If we are required to raise additional capital, doing so may cause dilution to our stockholders, restrict our operations or require us to relinquish certain rights to our technologies or product candidates
7. 20Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults or non-performance by financial institutions could adversely affect our current financial condition and projected business operations

Risks Related to Our Dependence on Third Parties

1. 21Our collaboration with Kyowa Kirin is important to our business. If Kyowa Kirin ceases development efforts under our collaboration agreement, or if our collaboration agreement is terminated, we may not receive future milestone payments or royalties under the agreement and our business could be adversely affected
2. 22the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us
3. 23Our product candidates and any products that we may develop may compete with other product candidates and products for access to manufacturing facilities. There are a limited number of manufacturers that operate under cGMP regulations and that might be capable of manufacturing for us

Risks Related to Regulatory Approval of Our Product Candidates and Other Legal Compliance Matters

1. 24If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals in some or all planned regions, we will not be able to commercialize, or may be delayed in commercializing, our product candidates, and our ability to generate revenue will be materially impaired
2. 25A Breakthrough Therapy Designation by the FDA may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that our product candidates will receive marketing approval
3. 26Failure to obtain marketing approval in international jurisdictions would prevent our product candidates from being marketed abroad
4. 27injunctions or the imposition of civil or criminal penalties
5. 28The FDA and other regulatory agencies may require more extensive or expensive trials for combination product candidates than may be required for single agent pharmaceuticals
6. 29We may not be able to benefit from available regulatory exclusivity periods for tipifarnib if another company obtains regulatory approval for tipifarnib before we do
7. 30We may not be able to obtain orphan drug exclusivity for the product candidates for which we seek it, which could limit the potential profitability of such product candidates
8. 31analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers
9. 32Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and affect the prices we may obtain
10. 33Governments outside the United States tend to impose strict price controls, which may adversely affect our revenues, if any
11. 34If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business

Risks Related to Our Intellectual Property

1. 35We intend to rely upon a combination of regulatory exclusivity periods, patents, trade secret protection, trademarks, confidentiality agreements, and license agreements to protect the intellectual property related to our current product candidates and development programs
2. 36We are pursuing additional U.S. and foreign patents for ziftomenib; however, there is no guarantee that any such patents will be granted or that, if granted, would provide protection against third parties
3. 37We depend on our licensors to prosecute and maintain patents and patent applications that are material to our business. Any failure by our licensors to effectively protect these intellectual property rights could adversely impact our business and operations
4. 38If we breach any of the agreements under which we license from third parties the development and/or commercialization rights to our product candidates, we could lose license rights that are important to our business and our operations could be materially harmed
5. 39the priority of invention of patented technology
6. 40The patent applications of pharmaceutical and biotechnology companies involve highly complex legal and factual questions, which, if determined adversely to us, could negatively impact our patent position
7. 41Changes in U.S. patent law, or laws in other countries, could diminish the value of patents in general, thereby impairing our ability to protect our product candidates
8. 42Patent terms may be inadequate to protect our competitive position on our product candidates for a commercially meaningful length of time
9. 43Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
10. 44We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful
11. 45Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business
12. 46We may not be successful in obtaining or maintaining necessary third-party intellectual property rights for our development pipeline through acquisitions and in-licenses
13. 47If we are unable to maintain the confidentiality of our trade secrets or other confidential information, our business and competitive position would be harmed
14. 48We may not be able to protect our intellectual property rights throughout the world

Risks Related to the Commercialization of Our Product Candidates

1. 49Even if any of our product candidates receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success
2. 50any restrictions on the use of our products together with other medications
3. 51We face substantial competition, which may result in others discovering, developing or commercializing competing products before or more successfully than we do
4. 52The insurance coverage and reimbursement status of newly-approved products are uncertain. Failure to obtain or maintain coverage and adequate reimbursement for new or current products could limit our ability to market those products and decrease our ability to generate revenue
5. 53Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop
6. 54the inability to commercialize any products that we may develop

Risks Related to Employee Matters, Managing Growth and Macroeconomic Conditions

1. 55We are highly dependent on our Chief Executive Officer. Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel
2. 56We have expanded, or expect to expand, our development, regulatory, operations, medical affairs, market access, marketing and sales capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations
3. 57Third-party expectations relating to environmental, social and governance factors may impose additional costs and expose us to new risks
4. 58Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations
5. 59In the ordinary course of our business, we and the third parties with whom we work process sensitive data, and, as a result, we and the third parties with whom we work face a variety of evolving threats that could cause security incidents
6. 60Our business and operations would suffer in the event of system failures
7. 61Actual or threatened public health epidemics or outbreaks may adversely impact our industry, including our clinical trials, our supply chain, our liquidity and access to capital markets and our business development activities
8. 62Our operations are vulnerable to interruption by natural disasters, power loss, terrorist activity and other events beyond our control, the occurrence of which could materially harm our business

Risks Related to Ownership of our Common Stock

1. 63Our stock price may fluctuate significantly and you may have difficulty selling your shares based on current trading volumes of our stock
2. 64The price of our common stock may be volatile and may be influenced by numerous factors, some of which are beyond our control
3. 65other events or factors, many of which are beyond our control
4. 66We have broad discretion in the use of our cash and may not use our cash effectively, which could adversely affect our results of operations
5. 67FINRA sales practice requirements may limit a stockholder’s ability to buy and sell our stock
6. 68The resale of shares covered by our effective shelf registration statements could adversely affect the market price of our common stock in the public market, which result would in turn negatively affect our ability to raise additional equity capital
7. 69We will incur increased costs and demands upon management as a result of complying with the laws and regulations affecting public companies, which could harm our operating results
8. 70If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired, which could harm our operating results, our ability to operate our business and investors’ views of us
9. 71We expect that significant additional capital will be needed in the future to continue our planned operations. To raise capital, we may sell common stock, convertible securities or other equity securities in one or more transactions at prices and in a manner we determine from time to time
10. 72In addition, we may grant or provide for the grant of rights to purchase shares of our common stock pursuant to our 2015 Employee Stock Purchase Plan, or ESPP. As of December 31, 2024, we had 558,608 shares of common stock reserved for future issuance under the ESPP
11. 73Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a change of control which could limit the market price of our common stock and may prevent or frustrate attempts by our stockholders to replace or remove our current management
12. 74Our charter documents provide that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees
13. 75any action asserting a claim against us governed by the internal affairs doctrine
14. 76Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition or results of operations
15. 77Our ability to use net operating loss carryforwards and certain other tax attributes to offset future taxable income or taxes may be limited
16. 78We do not intend to pay cash dividends on our capital stock in the foreseeable future
17. 79If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about us, our business or our market, our stock price and trading volume could decline
18. 80Our business could be negatively affected as a result of actions of activist stockholders, and such activism could impact the trading value of our securities
19. 81Securities class action litigation could divert our management’s attention and harm our business and could subject us to significant liabilities
20. 82Our employees, independent contractors, principal investigators, consultants, vendors, distributors and CROs may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements